A few small and uncontrolled studies have reported promising
results with the interferon/ribavirin (IFN/Rib) combination as
therapy for chronic hepatitis C; especially among patients with a
previous non-sustained or non-response to IFN alone. We have
evaluated the efficacy and safety of a 24 week IFN/Rib course,
compared to IFN/placebo. 100 patients, previously not treated with
IFN, ribavirin or any other antiviral drug for hepatitis C, were
randomized in a double-blinded fashion to receive IFN alpha-2b 3 MU
subcutaneously thrice weekly in combination with either oral
ribavirin, at a dose of 1000-1200 mg/day (50 patients), or placebo
(50 patients). Follow-up after treatment cessation was for 24
weeks. The study groups were comparable with regard to age, gender,
mode of acquisition, liver histology, pretreatment ALT level,
pretreatment HCV RNA level and genotype.

There was no significant difference in biochemical or
virological response at treatment cessation. Thus, a biochemical
response with normalization of ALT was seen in 32/50 patients (64%)
in the IFN/Rib group, and in 28/50 patients (56%) in the
IFN/placebo group. The virological response, with eradication of
viremia, was 26/50 (52%) for both study groups. In contrast, at the
end of follow-up, a sustained biochemical response was seen in
23/50 patients (46%) in the IFN/Rib group, and in 11/50 patients
(22%) in the IFN/placebo group (p<0.05). Furthermore, in sera
analyzed so far, the sustained virological response was 20/44 (45%)
and 10/43 (23%) in the IFN/Rib and IFN/placebo groups, respectively
(p<0.05). The sustained virological response rate for genotype
3a was significantly better than for genotype 1a and 1b (50% vs 19
and 18% respectively in the total study population; p<0.05).
Age, gender, liver histology and pretreatment ALT and HCV RNA
levels did not affect treatment outcome. Four patients discontinued
treatment due to side-effects; all in the IFN/Rib study group.
Patients who received IFN/Rib had lower haemoglobin (p=0.0001) and
higher uric acid levels (p<0.05) than IFN/placebo patients at
treatment cessation. The changes were reversible after treatment
cessation.